(1)

The European Medicines Agency (‘the Agency’), in collaboration with the Member States and the Commission, set up a portal at Union level as a single entry point for the submission of data and information relating to clinical trials (‘EU portal’), as required by Article 80, first subparagraph, of Regulation (EU) No 536/2014.

(2)

The Agency, in collaboration with the Member States and the Commission, set up an EU database at Union level, that will contain the data and information submitted in accordance with Regulation (EU) No 536/2014 (‘EU database’), as required by Article 81(1) of that Regulation.

(3)

On 25 March 2015, the Agency published the functional specifications for the EU portal and the EU database to be audited (2), which it had drawn up in collaboration with the Member States and the Commission as required by Article 82(1) of Regulation (EU) No 536/2014.

(4)

On 21 April 2021, the Management Board of the Agency, on the basis of the independent audit report delivered on 8 April 2021, informed the Commission in accordance with Article 82(2) of Regulation (EU) No 536/2014 that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications published by the Agency.

(5)

On the basis of the information provided by the Management Board of the Agency, the Commission verified that the EU portal and the EU database fulfilled the conditions of full functionality and of compliance with those functional specifications.

(6)

Regulation (EU) No 536/2014 is to apply as from six months after the publication of a notice in the Official Journal of the European Union in accordance with Article 99, second paragraph, of that Regulation. This Decision should therefore enter into force as a matter of urgency,